The drug achieved the results without evidence of post operative residual curarization (PORC) or re-occurrence of muscle relaxation, Organon added. The trial compared the efficacy of sugammadex and neostigmine for the reversal of shallow neuromuscular blockade induced by single or multiple doses of either rocuronium (Esmeron/Zemuron) or vecuronium (Norcuron).
Reversal agents are used during general anesthesia to reverse the effects of muscle relaxants, also called neuromuscular blocking agents. Reversal of neuromuscular blockade is used to reduce the risk of PORC or re-occurrence of muscle relaxation.
Sugammadex’s global phase III development program – consisting of five US trials and five European trials – completed recruitment in late 2006. The submission of the registration files for the US, Europe and Japan are on schedule.